MEQUON, Wis.--(BUSINESS WIRE)--ENDECE, LLC announced the issuance of an additional United States (U.S.) patent protecting its lead investigational compound, NDC-1308, for inducing the process of remyelination, the restoration of the myelin sheath on demyelinated axons in patients with multiple sclerosis (MS). The newly issued patent, No. 9,364,486, entitled, “6-Substituted Estradiol Derivatives for Use in Remyelination of Nerve Axons,” specifically covers the use of NDC-1308 for inducing remyelination of demyelinated axons in the brain and spinal cord, defects that are commonly associated with disabilities in patients with neurological diseases such as MS.
“In addition to strengthening ENDECE’s intellectual property portfolio, this additional patent bolsters our position that remyelination is possible in patients with MS, and will help advance the clinical development programs for NDC-1308 and other potential treatments for neurodegenerative diseases,” commented James Yarger, Ph.D., chief executive officer of ENDECE, LLC. “In preclinical models, NDC-1308 readily crosses the blood-brain barrier and induces oligodendrocyte progenitor cells to differentiate into mature oligodendrocytes, which then synthesize and maintain the protective myelin sheath. Importantly, these studies demonstrated NDC-1308, an estradiol analog, gained this unique ability to induce remyelination while losing the estrogenic characteristics of estradiol.”
The myelin sheath is an insulating envelope of myelin (a white, fatty material, composed chiefly of lipids and lipoproteins) that surrounds the core of axons and serves as an electrical insulator, allowing signals to be transmitted rapidly from the nervous system to the rest of the body. Demyelination is a process involving the loss of myelin, followed by slowing and often stopping of the nerve signals. The continuing demyelination of axons in patients with MS is often associated with an increasing loss of function including impairments in cognition, vision, and walking, as well as symptoms such as muscle weakness, fatigue, and bladder and bowel problems. Remyelination can restore conduction properties to axons, thereby restoring varying degrees of neurological function. However, remyelination becomes increasingly incomplete and eventually fails in the majority of patients with MS, leading to more progressive forms of the disease. Whereas currently available drugs for MS effectively slow advancement of the disease from the initial relapsing remitting (RRMS) stage to its secondary progressive (SPMS) stage, these agents only address the inflammatory components of the disease and do not induce remyelination.
In addition to U.S. Patent No. 9,364,486, ENDECE has received patents in Europe, Canada, Australia, China, and Singapore covering NDC-1308 for inducing remyelination. To protect the novel chemical structure of NDC-1308 and related compounds within the company’s proprietary compound library, ENDECE has also been issued Composition of Matter and Use patents in the U.S. and in major international markets.
NDC-1308 is a proprietary chemical entity designed to address demyelination of the myelin sheath that occurs in patients with MS. NDC-1308 is being developed for potential use either alone or in combination with current MS therapeutics that slow the progression of the disease. By dramatically up-regulating key genes in pathways that induce oligodendrocyte progenitor cell (OPC) differentiation and myelin synthesis, NDC-1308 repairs the demyelinated myelin sheath that is believed to be the cause of the devastating symptoms of MS. In preclinical models, the small molecule NDC-1308 has been shown to readily cross the blood-brain barrier, allowing it to reach the tissues in the brain and spinal cord where promoting myelin repair is needed. ENDECE discovered NDC-1308 and owns the intellectual property surrounding the compound. For more information, visit www.endece.com.
ENDECE, LLC (ENDECE), founded in 2006, is a privately held biopharmaceutical drug discovery and development company based in Wisconsin. The company focuses on small-molecule compounds that control key genes within specific signaling pathways as a platform for discovering drugs capable of treating diseases for which there are no cures. ENDECE’s scientists have created a proprietary library of compounds having the potential to treat diseases such as multiple sclerosis (MS) and Alzheimer’s disease.
ENDECE’s business strategy is to discover and develop drug candidates through Phase 1 clinical studies and then secure a licensing partner with expertise in all phases of clinical development and commercialization. ENDECE is led by an experienced management team with a proven ability to take drug candidates from discovery through clinical studies.